MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; KP SINGLE BASIN SURE SET RF

Catalog Number	DYNJS3071
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that as the gauze component was being removed from the surgical site, during a paraesophageal hernia procedure, the gauze was shredding into the surgical site.A pair of forceps was used by the surgeon to remove the gauze material from the surgical site.The patient was under general anesthesia at the time of this incident and the length of the case of was prolonged due to the shredding of the gauze, but there was no reported impact or adverse effect to the patient, the patient's stability, or the patient's plan of care as a result of the reported incident.The reporting facility indicated that no sample was available to be returned to the manufacturer for evaluation.A root cause for the reported incident could not be determined.Due to the need for medical intervention to remove the shredded gauze from the surgical site, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the gauze shredded while inside of a patient.

• Common Device Name: KP SINGLE BASIN SURE SET RF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8957115
• Report Number: 1423395-2019-00032
• Device Sequence Number: 14093180
• Product Code: LRO
• UDI-Device Identifier: 10888277248908
• UDI-Public: 10888277248908
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJS3071
• Device Lot Number: 19EBS961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 78